Method and apparatus for anastomosis including an anchoring sleeve

ABSTRACT

Apparatus for performing a surgical anastomosis are disclosed. The apparatus include a tubular body having a proximal end and a distal end, an onion sleeve portion formed near the distal end of the tubular body and an inner tube disposed within the tubular body. The inner tube includes at least one pair of longitudinally aligned needle passages formed below the onion sleeve portion of the tubular body. The apparatus further includes at least one needle assembly disposed within the at least one pair of longitudinally aligned needle passages and a firing assembly operatively coupled to the proximal end of the tubular body. The firing assembly is configured and adapted to eject the pair of needles from the apparatus.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a National Stage Application of PCT/US 03/11692 under 35 USC§371 (a), which claims priority of U.S. Provisional Patent ApplicationSer. No. 60/390,782 filed Jun. 20, 2002, now abandoned, the entirecontents of which are hereby incorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to apparatus and methods for anastomosingtwo hollow body parts and, more particularly apparatus and methods foranastomosing a urethral stump of a patient to the bladder following aradical prostatectomy.

2. Background of Related Art

Anastomosis is the bringing together and/or joining of hollow or tubularstructures. Most body conduits are generally cylindrical inconfiguration and have a circular cross-section. When it is desired tosuture such a conduit, typically for attachment to another body conduit,sutures are placed around the circumference of the conduit in order tomaintain the patency of its lumen or channel. This type of attachment iscommonly referred to as an anastomosis. It can be appreciated that thesutures made on top of the conduit (i.e., on the side facing thesurgeon) in an anastomosis are made relatively more easily than thesutures made underneath the conduit (i.e., on the side facing away fromthe surgeon).

The complexity of anastomosis attachment is made manifestly apparent ina surgical procedure referred to generally as a radical prostatectomy(i.e., a well established surgical procedure for patients with localizedprostatic carcinoma). In general, radical prostatectomy proceduresrequire the removal of cancerous tissue while preserving sexual functionand continence in the patient. There are two primary types of radicalprostatectomy approaches for the removal of prostate cancer, theretropubic approach and the perineal approach.

In the retropubic approach, a long up-and-down incision is made in themidline of the abdomen from the navel to the pubic bone. After the lymphnodes have been removed for study by the pathologist and a determinationhas been made to proceed with the removal of the prostate gland, thespace underneath the pubic bone is cleaned and dissected and the removalof the entire prostate gland is generally begun at the end that isfarthest from the bladder, i.e., next to the external urethralsphincter. Next, the prostatic urethra is divided, the prostatic urethraand the prostate gland through which it goes are then pulled upwardstoward the bladder while the dissection continues behind the prostategland, separating it from the layer of tissue that is connected to therectum on its other side. As the dissection continues between theprostate and the rectum, the seminal vesicles, which are behind the baseof the bladder will be removed along with the prostate gland. Once theseminal vesicles are free, the entire prostate gland and the seminalvesicles are removed. The bladder neck is then stitched closed to asmall enough diameter so that it is about the same size as the stump ofthe urethra from which the prostate was detached. The bladder neck isthen pulled down into the pelvis and positioned against the urethralstump and stitched thereto. This stitching is done typically around aFoley catheter which has been inserted through the penis all the wayinto the bladder.

In the perineal approach, an inverted “U” shaped incision is made goingright over the anus, with the center of the “U” about three centimetersabove the margin of the anus. The prostate gland is then freed from itssurrounding structures by gentle dissection, and the urethra at the endof the prostate farthest from the bladder is isolated and divided. Thebladder neck is freed from the prostate, and, once the prostate glandhas been removed and the bladder neck has been closed sufficiently sothat the size of its opening approximates the size of the urethralopening, the urethra and the bladder neck are stitched together. Onceagain, a Foley catheter is left in place postoperatively for about twoweeks.

In each of the above described procedures, it is the attachment of theurethral stump to the bladder neck which is particularly difficult andcomplex. This difficulty is complicated by the tendency of the urethralstump to retract into adjacent tissue. As a result, considerable timeand effort must be expended to re-expose the urethral stump and beginthe re-anastomosis procedure. Further complicating this procedure is thefact that the urethral stump is hidden beneath the pubic bone thusrequiring that the surgeon work at a difficult angle and in positionsthat are uncomfortable and limiting.

Various devices have been proposed for facilitating this procedure. InU.S. Pat. No. 5,591,179 issued to Edelstein there is disclosed asuturing device including a shaft with portions defining an interiorchannel extending between a proximal and a distal end of the shaft. Thischannel includes a generally axial lumen which extends to the proximalend of the shaft and a generally transverse lumen which extends from theaxial lumen distally outwardly to an exit hole at the outer surface ofthe shaft. A needle and suture can be back loaded into the transverselumen of the channel while a generally non-compressible member can bemovably mounted in the axial lumen of the channel. At the proximal endof the shaft a handle is provided with means operative to push themember distally through the lumen to deploy or expel the needle.

In U.S. Pat. No. 4,911,164 issued to Roth there is disclosed a sutureguide with a curved distal portion. The distal portion of the sutureguide has a plurality of exterior axial grooves which can be used toalign and guide a curved needle and attached suture. In order to drivethe urethral stump to an accessible position, the device is providedwith a plurality of outwardly extendable members which engage the lumenof the urethra. These members make it possible to push the urethralstump into approximation with the bladder neck.

In U.S. Pat. No. 5,047,039 issued to Avant et al. there is disclosed asurgical device for the ligation of a dorsal vein and subsequentanastomosis. This device contains a pair of enclosed needles each havingan attached suture which needles may be driven from the shaft of thedevice into adjacent tissue.

In general, none of the devices disclosed in the prior art referencesabove is simple to use or makes the anastomosis of the urethral stump tothe bladder neck easier. As such, each surgical procedure using priorart devices continues to be time consuming and requires great skill inorder to be performed. In addition, these prior art references do notdisclose a suture device which can accurately position a plurality ofanchor and suture combinations, for use at or near the severed end of abody conduit, simultaneously. Accordingly, the need exists for radicalprostatectomy anastomosis devices which overcome the drawbacks of theprior art devices and which are quick and simple to use.

SUMMARY OF THE INVENTION

Apparatus and methods for performing a surgical anastomotic procedureare disclosed herein. The apparatus according to the present disclosureincludes a tubular body having a proximal end and a distal end and anonion portion formed near the distal end of the tubular body forengaging a first body vessel. The onion portion has a first position anda second position outside the radial dimension of the tubular body. Theapparatus has an inner tube disposed within the tubular body andslidably movable to deploy the onion portion from the first position tothe second position. The inner tube has a plurality of passages. Theapparatus has a plurality of needles, each needle being disposed in oneof the passages. The apparatus has a firing assembly for deploying theneedles from the passages.

The tubular body may have a first position in which the onion sleeveportion is substantially co-planar with the tubular body and a secondposition in which the onion sleeve portion is deployed transversely withrespect to the tubular body.

The inner tube may be slidably movable from a first position in whichthe onion sleeve portion is in the first position and a second positionin which the onion sleeve is in the second position. The passages maycomprise a pair of passages formed below the onion sleeve portion of thetubular body, including a distal passage and a proximal passage.Preferably, the pair of passages are oriented toward one another.

The needles may comprise at least one needle assembly disposed withinthe pair of passages. Each needle assembly includes a pair of needlesinterconnected by a suture. A first needle of the pair of needles isdesirably disposed within the distal passage and a second needle of thepair of needles is desirably disposed within the proximal passage.

The firing assembly desirably includes a plurality of rods, each of therods being operatively coupled to at least one of the needles. Thefiring assembly may include a first needle driver knob and a secondneedle drive knob. The first needle driver knob is operatively coupledto at least one first rod with the at least one first rod desirablycoupled with the first needle of the pair of needles. Preferably, distaladvancement of the first rod causes the first needle of the pair ofneedles to be ejected from the apparatus. Preferably, proximaladvancement of the second rod causes the second needle of the pair ofneedles to be ejected from the apparatus.

A preferred method for joining a first body vessel and a second bodyvessel comprises passing an apparatus through the second body vessel,the apparatus having an onion portion, so that the onion portion isreceived in the first body vessel. The first body vessel and second bodyvessel are approximated and joined, including deploying the onionportion so that the onion portion moves to a position outside the radialdimension of a tubular body of the apparatus and deploying at least oneneedle into at least one of the first body vessel and the second bodyvessel. The apparatus may have an inner tube with at least one pair ofpassages including a first passage and a second passage. The apparatusfurther includes at least one needle assembly disposed within thepassages with each needle assembly including a pair of needlesinterconnected by a suture. Preferably, a first needle of the pair ofneedles in disposed within the first passage and a second needle of thepair of needles is disposed within the second passage.

These and other advantages and features of apparatus and methodsdisclosed herein, will become apparent through reference to thefollowing description of embodiments, the accompanying drawings and theclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with the general description given above, and the detaileddescription of the embodiments given below, serve to explain theprinciples of the present disclosure.

FIG. 1 is a perspective view of an anastomosis apparatus constructed inaccordance with the present disclosure, while in a retracted position,as seen from a distal end thereof;

FIG. 1A is a perspective view of an engineering model of the anastomosisapparatus of FIG. 1, while in a retracted position;

FIG. 1B is a perspective view of an engineering model of the anastomosisapparatus of FIG. 1, while in a deployed position;

FIG. 2 is an enlarged perspective view of a distal end of the apparatusof FIG. 1, illustrating a radially deformable onion sleeve in aretracted configuration;

FIG. 2A is an enlarged perspective view of an engineering model of theanastomosis apparatus of FIG. 2;

FIG. 3 is an enlarged perspective view of the distal end of theapparatus of FIG. 1, illustrating the radially deformable onion sleevein a deployed configuration;

FIG. 3A is an enlarged perspective view of an engineering model of theanastomosis apparatus of FIG. 3;

FIG. 4A is an enlarged perspective view of an engineering model of aproximal end of the apparatus of FIG. 1A, while in the retractedposition;

FIG. 4B is an enlarged perspective view of an engineering model of aproximal end of the apparatus of FIG. 1B, while in the deployedposition;

FIG. 5 is a cross-sectional view of the distal end of the apparatus ofFIG. 1, taken along a longitudinal axis thereof;

FIG. 6 is a side elevational view of a needle suture assembly inaccordance with the present disclosure;

FIG. 7 is a partial cross-sectional view of a portion of a urinarysystem of a patient with a distal end of the apparatus of FIG. 1deployed therein with the radially deformable onion sleeve in theretracted configuration;

FIG. 8 is a partial cross-sectional view of a portion of the urinarysystem with the distal end of the apparatus of FIG. 1 deployed thereinwith the radially deformable onion sleeve of the expanded and positionedto draw the bladder into apposition with the urethral stump;

FIG. 9 is a cross-sectional view of a portion of the urinary system withthe apparatus of FIG. 1 deployed therein and the radially deformableonion sleeve expanded and tissue anchors deployed into the bladder andthe urethral stump; and

FIG. 10 is a partial cross-sectional view of a portion of the urinarysystem with the apparatus of FIG. 1 being withdrawn through the urethra

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed anastomosis apparatuswill now be described in detail with reference to the drawing figureswherein like reference numerals identify similar or identical elements.In the drawings and in the description which follows, the term“proximal”, as is traditional will refer to the end of the surgicaldevice or instrument of the present disclosure which is closest to theoperator, while the term “distal” will refer to the end of the device orinstrument which is furthest from the operator.

Referring now to FIGS. 1-10, an anastomosis apparatus, in accordancewith the principles of the present disclosure, is shown generally asreference numeral 100. Although apparatus 100 offers significantadvantages to a radical prostatectomy procedure, it will be understoodthat the device is applicable for use in any anastomotic procedure wheretwo body conduits are to be joined, such as where the end of a conduitis to be sutured to a hollow body organ.

As seen in FIG. 1, apparatus 100 includes a tubular body 102 having adistal end 104 and a proximal end 106. Tubular body 102 includes anonion sleeve portion 108 formed near distal end 104. Preferably, onionsleeve portion 108 includes a plurality of longitudinally aligned slots110 formed therein. Slots 110 define a plurality of longitudinal ribs112 each having a number of transverse folding lines 114 formed alongthe length thereof. Preferably, as seen in detail in FIG. 3, each rib112 includes a pair of fold lines 114A formed along the inner surfacethereof and a fold line 114B, located between fold lines 114A, formedalong the outer surface of rib 112.

In accordance with the present disclosure, tubular body 102 is movablefrom a first insertion/withdrawal position to a second operativeposition. In the first insertion/withdrawal position (see FIGS. 1, 1A, 2and 2A), distal end 104 of tubular body 102 is at a distal most positionsuch that longitudinal ribs 112 of onion sleeve portion 108 lie flushwith the outer surface of tubular body 102. Meanwhile, in the operativeposition (see FIGS. 1B, 3 and 3A), distal end 104 of tubular body 102 isat a proximal most position wherein longitudinal ribs 112 of onionsleeve portion 108 extend radially outward from tubular body 102.

Apparatus 100 desirably further includes a hollow inner tube 120received within and extending through tubular body 102, an onion sleeveportion trigger 122 and an onion sleeve portion slider 124 each slidablydisposed on tubular body 102. In the embodiments shown, the inner tube120 is provided with a threaded distal end 126. Threaded distal end 126threadably receives a back-up ring 128 thereon. Back-up ring 128 acts toabut the distal end of tubular body 102 in a manner such that inner tube120 is prevented from being proximally withdrawn from tubular body 102.

As seen in FIG. 1, trigger 122 preferably includes a cylindrical bodyportion 130 defining a lumen 132 therethrough and a pair of handles 134extending radially therefrom. Trigger 122 includes a locking screw 136oriented to extend through body portion 130 of trigger 122 and to engagethe outer surface of tubular body 102. In use, tightening of lockingscrew 136 will secure trigger 122 against tubular body 102 and preventaxial movement of trigger 122 along tubular body 102. In the embodimentshown, trigger 122 is coupled to inner tube 120 such that axialreciprocal movement of trigger 122 along tubular body 102 will causeinner tube 120 to reciprocally slide within tubular body 102.

Slider 124 includes an annular collar 138 having a flange 140 extendingtherefrom and a locking screw 142 oriented to extend through annularcollar 138 and to engage the outer surface of tubular body 102. In use,tightening of locking screw 142 will secure slider 124 against tubularbody 102 and prevent axial movement of slider 124 along tubular body102.

Apparatus 100 further includes a firing assembly 144 operativelyconnected to a proximal end of inner tube 120. Firing assembly 144includes a central body portion 146 having a proximal needle driver knob148 and a distal needle driver knob 150 threadingly coupled thereto. Asseen in FIG. 5, firing assembly 144 further includes a plurality ofperipheral firing rods 152 extending through inner tube 120, betweenproximal needle driver knob 148 and a corresponding plurality ofradially oriented suture needle passages 154 formed near a distal end ofinner tube 120. In accordance with the present disclosure, suture needlepassages 154 are distally oriented and are radially aligned with slots110 of tubular body 102.

Firing assembly 144 additionally includes a central firing rod 156extending through inner tube 120, between distal needle driver knob 150and a plurality of radially oriented suture needle passages 158 formednear a distal end of inner tube 120. Preferably, suture needle passages158 are formed distally of needle passages 154, are oriented in aproximal direction and are radially aligned with slots 110 of tubularbody 102. Central firing rod 156 includes a plurality of proximallyoriented prongs 160 configured and adapted to be received within needlepassages 158.

In one embodiment, central firing rod 156 includes a distal tip 162which extends through the distal end of inner tube 120. Distal tip 162acts like a guide wire and aides the surgeon in guiding and insertingapparatus 100 through the urethra of the patient.

Apparatus 100 further includes needle assembly 164 (see FIG. 6) having apair of needles 166 interconnected by a suture tether 168. Preferably,each needle 166 includes a sharpened end 170 and a recess 172 formed inthe opposite end thereof. In accordance with the present disclosure,needle assembly 164 is coupled to apparatus 100 such that a first needle166 is positioned in needle passage 158 and a second needle 166 ispositioned in needle passage 154, wherein each needle 166 is orientedwith sharpened end 170 oriented radially outward. Accordingly, recess172 of each needle 166 is configured and adapted to be seated on thedistal ends of firing rods 152, 156. In accordance with the presentdisclosure, suture tether 168 extends from a first needle 166, outthrough needle passage 154, along the outer surface of inner tube 120,into needle passage 158 and to a second needle 166.

In accordance with the present disclosure, it is preferred that fiveneedle assemblies 164 be operatively received within a correspondingnumber of respective needle passages 154 and 158. While a set of fiveneedle assemblies 164 is preferred, it is envisioned that any number ofneedle assemblies 164 can be used. It is contemplated that needles 166of needle assemblies 164 can be made from any surgical grade material,such as stainless steel or titanium, however, it is envisioned thatneedles 166 are preferably made from a medical grade bio-absorbablematerial, such as, for example, polyglycolic acid (PGA) and/orpolylactic acid (PLA). It is further envisioned that suture tether 168of needle assembly 164 also be made of a suitable bio-absorbablematerial.

A preferred method of use and operation of anastomosis apparatus 100 inperforming a radical prostatectomy anastomosis will now be described ingreater detail with reference to FIGS. 1-10 and in particular withreference to FIGS. 7-10. Apparatus 100 can be used in either theretropubic or the perineal prostatectomy approaches. With the prostateremoved, the bladder neck “N” of the bladder “B” is first reconstructedby everting the inner mucosal lining of bladder “B” and suturing it downto the outer wall of bladder “B”, using known surgical techniques.Likewise, urethral stump “S” of urethra “U” is reconstructed by evertingthe inner mucosal lining of urethral stump “S” and suturing it down tothe outer wall of urethra “U”, using known surgical techniques.

Preferably, with bladder neck “N” reconstructed, bladder neck “N” issized to properly accommodate and retain bladder fitting 104 withinbladder “B” using a standard tennis racket type closure (i.e., theopening of the bladder neck constituting the head of the tennis racketand a radial incision extending from the bladder neck constituting thehandle portion of the tennis racket. Most preferably, bladder neck “N”is sized to be approximately 7-8 mm in diameter.

With bladder neck “N” reconstructed, apparatus 100 is passedtrans-urethrally through urethra “U” until distal end 104 of tubularbody 102 extends out of urethral stump “S”, as indicated by arrow “A” inFIG. 7. In particular, distal end 104 of tubular body 102 is positionedsuch that the distal end of urethral stump “S” is positioned distally ofneedle passages 154.

With apparatus 100 so positioned, proximal needle driver knob 148 isrotated about central body portion 146. The rotation of driver knob 148results in the distal advancement of peripheral firing rods 152 throughinner tube 120. As such, proximal needles 166 are radially ejected outthrough suture needle passages 154 and into urethral stump “S”, as seenFIG. 7. Driver knob 148 is advanced until proximal needles 166completely pass through urethral stump “S” at which time driver knob 148is rotated in an opposite direction in order to withdraw peripheralfiring rods 152 back into inner tube 120.

Next, apparatus 100 is further advanced distally until distal end 104 oftubular body 102 enters bladder neck “N” of bladder “B”. In accordancewith the present disclosure, apparatus 100 is distally advanced intobladder “B” until onion sleeve portion 108 of tubular body 102 ispositioned distally of bladder neck “N”. With apparatus 100 sopositioned, onion sleeve portion 108 of tubular body 102 is deployed. Inaccordance with the present disclosure, onion sleeve portion 108 isdeployed by locking slider 124 in place against tubular body 102,holding slider 124 and advancing trigger 122 in a proximal directionrelative to slider 124, i.e., in a direction indicated by arrow “C” ofFIGS. 4A and 4B. Accordingly, proximal movement of trigger 122 relativeto slider 124 results in the proximal movement of inner tube 120 throughtubular body 102. Since back-up ring 128 is secured to the distal end ofinner tube 120, proximal advancement of inner tube 120 through tubularbody 102 results in back-up ring 128 pressing against the distal end oftubular body 102 thereby causing onion sleeve portion 108 to compress.Compression of onion sleeve portion 108 results in the deflection ofribs 112 along fold lines 114A and 114B and thus in turn the radiallyexpansion of onion sleeve portion 108.

With onion sleeve portion 108 in the deployed position, trigger 122 issecured in place along tubular body 102 by tightening locking screw 136.Next, apparatus 100 is drawn in a proximal direction, as indicated byarrow “D” in FIG. 8, through urethra “U”. In so doing, ribs 112 ofexpanded onion sleeve portion 108 contact the inner surface of bladder“B” and act as an anchor to aid in the proximal drawing of bladder “B”until bladder neck “N” contacts urethral stump “S”.

With bladder “B” contacting urethral stump “S”, distal needle driverknob 150 is rotated about central body portion 146. The rotation ofdriver knob 150 results in the proximal advancement of central firingrod 156 through inner tube 120. As such, prongs 160 of central firingrod 156 press against needles 166 in order to radially eject needles 166out through suture needle passages 158 and into bladder neck “N” (seeFIG. 9). Driver knob 150 is advanced until distal needles 166 completelypass through bladder neck “N” at which time driver knob 50 is rotated inan opposite direction in order to withdraw prongs 160 of central firingrod 156 back in to inner tube 120.

Next, onion sleeve portion 108 is returned to the insertion position, inthe present instance the withdrawal position, by loosening locking screw136 of trigger 122 and proximally advancing trigger 122 (i.e., in adirection opposite to direction “C” as seen in FIGS. 4A and 4B). In sodoing, ribs 112 of onion sleeve portion 108 retract to lie flush withthe outer surface of tubular body 102. With onion sleeve portion 108returned to the insertion/withdrawal position, the surgeon withdrawsapparatus 100 proximally through urethra “U”, as seen in FIG. 10.

While the apparatus in accordance with the present disclosure has beendescribed as being used in connection with a radical prostatectomy, itis envisioned that apparatus having a similar structure and mode ofoperation can be used in various other surgical procedures. The methodsand apparatus disclosed herein may be used for approximating and/orjoining the urethra and bladder, intestinal portions of the body, bloodvessels or any other body vessels. It will be understood that variousmodifications may be made to the embodiments of the presently disclosedanastomosis device and method disclosed herein. For example, analternative mode of operation is envisioned in which apparatus 100 isadvanced distally through urethra “U” and into bladder “B”, onion sleeveportion 108 is deployed, apparatus 100 is retracted in order toapproximate bladder neck “N” with urethral stump “S”, firing knobs 148and 150 are sequentially fired in order to eject needles 166 of needleassembly 164 into bladder neck “N” and urethral stump “S”, respectively,onion sleeve portion 108 is retracted and apparatus 100 is withdrawnfrom urethra “U”.

The expandable anchor for engaging a first and/or second body vessel maycomprise any expandable structure, including those disclosed in certainembodiments of the following PCT Applications, all filed on an even dateherewith: application entitled Method And Apparatus For AnastomosisIncluding An Anchoring Sleeve, invented by Scott Manzo; Method AndApparatus For Anastomosis Including An Anchor For Engaging A Body VesselAnd Deployable Sutures, invented by Scott Manzo; Method And ApparatusFor Anastomosis Including Annular Joining Member, invented by ScottManzo; Method And Apparatus For Anastomosis Including Annular JoiningMember, invented by Scott Manzo; Method And Apparatus For AnastomosisIncluding An Expandable Member, invented by Russell Heinrich and ScottManzo; Method And Apparatus For Anastomosis Including An ExpandableAnchor, invented by Russell Heinrich and Scott Manzo; the disclosures ofwhich are all hereby incorporated by reference herein, in theirentirety.

The joining member for joining a first and/or second body vessel maycomprise any joining member, including those disclosed in certainembodiments of the following PCT Applications, all filed on an even dateherewith: application entitled Method And Apparatus For AnastomosisIncluding An Anchoring Sleeve, invented by Scott Manzo; Method AndApparatus For Anastomosis Including An Anchor For Engaging A Body VesselAnd Deployable Sutures, invented by Scott Manzo; Method And ApparatusFor Anastomosis Including An Anchor For Engaging A Body Vessel AndDeployable Sutures, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchoring Sleeve, invented by Scott Manzo;Method And Apparatus For Anastomosis Including Annular Joining Member,invented by Scott Manzo; Method And Apparatus For Anastomosis IncludingAnnular Joining Member, invented by Scott Manzo; Method And ApparatusFor Anastomosis Including An Expandable Member, invented by RussellHeinrich and Scott Manzo; Method And Apparatus For Anastomosis IncludingAn Expandable Anchor, invented by Russell Heinrich and Scott Manzo; thedisclosures of which are all hereby incorporated by reference herein, intheir entirety.

Therefore, the above description should not be construed as limiting,but merely as an exemplification of a preferred embodiment. For example,the locking screws may be replaced with a latch or any other structurefor locking the positions of the inner tube and tubular body withrespect to one another. In addition, the firing rods may be moved by anactivator that also moves in a proximal distal direction. The firingrods may also include separate firing rods for the proximal and distalneedles. Those skilled in the art will envision other modificationswithin the scope of the present disclosure.

1. An apparatus for joining a first body vessel and a second bodyvessel, comprising: a) a tubular body having a proximal end, a distalend and an onion portion integral to the tubular body, formed near thedistal end of the tubular body, and configured for engaging the firstbody vessel, the onion portion having a first position and a secondposition extending outside a radial dimension of the tubular body; b) aninner tube disposed within the tubular body and at least partiallywithin the onion portion, the inner tube being slidably movable todeploy the onion portion from the first position to the second position,the inner tube defining a plurality of passages; c) a plurality ofneedles, each needle being disposed in one of the plurality of passages;and d) a firing assembly for deploying the needles from the passages,the firing assembly including a first firing mechanism configured fordistal movement to deploy at least one of the needles in a distaldirection, and a second firing mechanism configured for proximalmovement to deploy at least one of the needles in a proximal direction.2. The apparatus of claim 1, wherein the passages comprise at least onepair of passages formed below the onion portion, including a proximaland a distal passage.
 3. The apparatus of claim 2, wherein the needlescomprise at least one needle assembly disposed within the at least onepair of passages, each needle assembly including a pair of needlesconnected by a suture.
 4. The apparatus of claim 3, wherein the at leastone needle assembly is arranged so that a first needle is disposed inthe proximal passage and a second needle is disposed in the distalpassage.
 5. The apparatus of claim 1, wherein the firing assemblyincludes a plurality of rods, each of the plurality of rods beingoperatively coupled to at least one of the needles.
 6. The apparatus ofclaim 5, wherein the firing assembly comprises a first knob operativelycoupled with at least one first rod, the at least one rod beingoperatively coupled with the first needle of the at least one needleassembly.
 7. The apparatus of claim 6, wherein the firing assemblycomprises a second knob operatively coupled with at least one secondrod, the at least one rod being operatively coupled with the secondneedle of the at least one needle assembly.
 8. The apparatus of claim 7,wherein distal advancement of the at least one first rod deploys thefirst needle and proximal advancement of the at least one second roddeploys the second needle.
 9. An apparatus for joining a first bodyvessel and a second body vessel, comprising: a) a tubular body having aproximal end, a distal end and an onion portion formed near the distalend of the tubular body, the onion portion having a first position and asecond position extending outside a radial dimension of the tubularbody, the onion portion configured for engaging the first body vesselwhen in the second position thereof; b) an inner tube disposed withinthe tubular body and being slidably movable to deploy the onion portionfrom the first position to the second position, the inner tube defininga plurality of passages; c) a plurality of needles, each needle beingdisposed in one of the plurality of passages such tat a sharpened end ofeach needle is oriented radially outward; and d) a firing assembly fordeploying the needles from the passages, the firing assembly including afirst firing mechanism configured for distal movement to deploy at leastone of the needles in a distal direction, and a second firing mechanismconfigured for proximal movement to deploy at least one of the needlesin a proximal direction.
 10. The apparatus of claim 9, wherein thepassages comprise at least one pair of channels formed radially inwardof the onion portion, each channel including a proximal and a distalsegment.
 11. The apparatus of claim 10, wherein the proximal segment andthe distal segment of each channel are oriented toward one another. 12.An apparatus for joining a first body vessel and a second body vessel,comprising: a) a tubular body having a proximal end, a distal end and anonion portion formed near the distal end of the tubular body, the onionportion having a first position and a second position extending outsidea radial dimension of the tubular body, the onion portion configured forengaging the first body vessel when in the second position thereof; b)an inner tube disposed within the tubular body and being slidablymovable to deploy the onion portion from the first position to thesecond position, the inner tube defining a plurality of passages; c) atissue anchor comprising a pair of needles interconnected by a suturetether, each of the pair of needles being disposed in one of theplurality of passages; and d) a firing assembly for ejecting the tissueanchor from the apparatus for implantation of one of the pair of needlesinto a respective one of the first and second body vessels, the firingassembly including a distal tip extending through a distal end of theinner tube.
 13. The apparatus of claim 12, wherein the pair of needlesand the suture tether are made from a medical grade bio-absorbablematerial.
 14. The apparatus of claim 13, wherein the medical gradebio-absorbable material is selected from the group consisting ofpolyglycolic acid and polylactic acid.